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The Tempus IC Professional is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel for the attended or unattended monitoring of single or multiple vital signs in clinical and pre-hospital care applications. The device is indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal CO2 (ETCO2), pulse oximetry (SpO2) and tympanic temperature.

The monitor is intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere).

The ECG Harness.of the Tempus IC Professional is suitable for use on adults or children (over 10 years old and over 20kg in weight).

The Tempus IC Professional is a multi-parameter vital signs monitor designed for use in prehospital care and remote clinical locations by trained healthcare professionals e.g. nurse. EMT, paramedic, physician, army corpsman etc. It provides 3 lead ECG monitoring, 12 lead ECG recording, pulse Oximetry, non-invasive blood pressure, sidestream Capnometry, a tympanic thermometer and user configurable alarms.

In addition, it provides the ability to transmit all vital signs data via wired or wireless Ethernet connections to a software system (called i2i) expected to be based in a facility far from the user e.g. a response centre facility. In addition to sending all vital signs, the system can also send pictures via an integrated camera, geographic position by an integrated GPS receiver and voice via a wired or wireless headset.

The device is intended to be used primarily as a standalone monitor for traditional monitoring applications. It is expected that its real-time telemedicine capabilities will be used in a minority of applications. When its telemedicine features are used it is intended that this will be for the purpose of obtaining support in the diagnosis and treatment decisions for the patient e.g. where the patient is in a remote country and the user's organisation needs to make an extraction or repatriation decision.

It is expected that the ability to transmit data in real-time will be performed in remote locations typically using satellite or terrestrial communications systems.

The provided text describes the Tempus IC Professional Patient Monitor, a multi-parameter vital signs monitor. However, it does not include detailed acceptance criteria tables with reported device performance metrics in the format requested. The document primarily focuses on regulatory approval (510(k)) and describes the device, its intended use, predicate devices, and various types of testing performed to demonstrate conformity to standards and equivalence to predicates.

Therefore, I cannot generate the requested table of acceptance criteria and reported performance directly from the provided text. The document states that "Comparative testing has been performed to demonstrate that the performance of the device is equivalent to the predicates. This comprised benchmarking against the Propaq for ECG and alarm performance and against the TH809 for temperature measurement performance." but does not provide specific numerical acceptance criteria or performance results from these comparative tests.

Similarly, much of the requested information regarding sample sizes, data provenance, expert ground truth, adjudication methods, and specific study designs (MRMC or standalone) are not available in the provided text. The document refers to general testing categories like AAMI EC13 for ECG, IEC standards for alarms and biocompatibility, and software validation but does not elaborate on the specific details of these studies in the context of the device's performance against defined acceptance criteria.

Based on the provided text, here is what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states that testing was performed to "demonstrate that the performance of the device is equivalent to the predicates" and to standards like AAMI EC13, IEC60601-1-8, etc., but it does not provide specific numerical acceptance criteria or the reported performance data for these parameters.

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided text. The document mentions "comparative testing" and "bench testing" but does not specify the sample sizes or the provenance (country of origin, retrospective/prospective) of the data used in these tests.

3. Number of Experts Used to Establish the Ground Truth and Their Qualifications

Not available in the provided text. Ground truth methods and expert qualifications are not described for any testing.

4. Adjudication Method for the Test Set

Not available in the provided text. Adjudication methods (e.g., 2+1, 3+1, none) are not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not available in the provided text. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. The device is a vital signs monitor and does not appear to involve AI assistance for human readers in diagnostic interpretation.

6. Standalone Performance Study

The document indicates that the device is primarily intended to be used as a "standalone monitor for traditional monitoring applications" and that "bench testing" was performed to confirm reliable and accurate data transmission. However, it does not detail a specific "standalone (i.e. algorithm only without human-in-the loop performance)" study with defined metrics. The closest mention is: "The design of this device utilises currently available (OEM) technology found in many legally marketed devices. In terms of measurement performance, the Tempus IC Professional is effectively identical to the devices that incorporate the same OEM technology." This suggests reliance on the performance characteristics of the OEM components rather than a novel algorithm's standalone performance.

7. Type of Ground Truth Used

Not explicitly stated in the provided text. Given the nature of the device (vital signs monitor benchmarking against predicate devices and industry standards), the ground truth for performance testing would likely be based on:

• Reference measurements from calibrated equipment: For parameters like ECG, NIBP, SpO2, ETCO2, and temperature, the accuracy would be compared against highly accurate reference devices or simulators during bench testing.
• Predicate device performance: "Comparative testing has been performed to demonstrate that the performance of the device is equivalent to the predicates." This implies the predicate devices' established performance serves as a comparative ground truth.

8. Sample Size for the Training Set

Not applicable/Not available in the provided text. The Tempus IC Professional is a vital signs monitor that utilizes OEM technology. The document does not describe any machine learning or AI algorithms that would require a "training set" in the conventional sense for a diagnostic device.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not available in the provided text. As there is no mention of a training set or machine learning algorithms, this information is not provided.

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